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FDA 510(k)

DLR-1 DERMA-LASE RUBY LASER/DLR-1/DERMA-LASE SYST

K-Number: K924647 · 1993-06-04

ApplicantDerma-Lase Co.
Decision Date1993-06-04
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DLR-1 DERMA-LASE RUBY LASER/DLR-1/DERMA-LASE SYST is the device name listed in this FDA 510(k) record. The listed applicant is Derma-Lase Co.. It received FDA 510(k) clearance on 1993-06-04 under 510(k) number K924647. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DLR-1 DERMA-LASE RUBY LASER/DLR-1/DERMA-LASE SYST?

DLR-1 DERMA-LASE RUBY LASER/DLR-1/DERMA-LASE SYST is a medical device that received FDA 510(k) clearance on 1993-06-04. The listed applicant is Derma-Lase Co.. The 510(k) number is K924647.

When did DLR-1 DERMA-LASE RUBY LASER/DLR-1/DERMA-LASE SYST receive FDA 510(k) clearance?

DLR-1 DERMA-LASE RUBY LASER/DLR-1/DERMA-LASE SYST received FDA 510(k) clearance on 1993-06-04, under 510(k) number K924647.

Who is the listed applicant for DLR-1 DERMA-LASE RUBY LASER/DLR-1/DERMA-LASE SYST?

The FDA 510(k) record lists Derma-Lase Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DLR-1 DERMA-LASE RUBY LASER/DLR-1/DERMA-LASE SYST?

The FDA product code for DLR-1 DERMA-LASE RUBY LASER/DLR-1/DERMA-LASE SYST is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Derma-Lase Co. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K932156MULTILINE; DLY-1K930975DERMA-LASE DLA-1 LASERK930793MULTILINE; DLY-1K913256DERMA-LASE RUBY LASER - MODEL DLR-1

Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.K252723Dynamis Pro FamilyFotona D.O.O.K241973SmartIPL_NI SystemLumenis Be, Ltd.K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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